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Articles |
1
Hennepin County Medical Center, Minneapolis, MN 55415.
2
Rush Presbyterian St. Luke's Medical Center, Chicago,
IL 60612.
3
Emory University Hospital, Atlanta, GA 30322.
4
University of Tennessee Memorial Hospital, Knoxville, TN
37920.
5
Columbia Presbyterian Medical Center, New York, NY
10032.
6
University of Maryland School of Medicine, Baltimore, MD
21201.
a Address correspondence to this author at: Hennepin County Medical Center, Clinical Laboratories 812, 701 Park Ave., Minneapolis, MN 55415. Fax 612-904-4229; e-mail fred.apple{at}co.hennepin.mn.us.
We evaluated the AxSYM troponin I (cTnI) immunoassay for assisting in
the detection of acute myocardial infarction (AMI). At four sites, the
total imprecision (CV) over 20 days was 6.310.2%. The minimum
detectable concentration was 0.14 ± 0.05 µg/L. Comparison of
cTnI measurements between the AxSYM and Stratus (n = 406) over the
dynamic range of the AxSYM assay demonstrated good correlation,
r = 0.881, with a proportional bias: AxSYM
cTnI = 3.50(Stratus cTnI) - 1.10. The confidence intervals (95%)
for the slope and intercept were 3.393.64 and -1.32 to -0.95,
respectively. The expected cTnI concentration in healthy individuals
was
0.5 µg/L, whereas the ROC curve-determined cutoff for AMI was
2.0 µg/L. This gave a diagnostic sensitivity of 91.8% and
specificity of 92.4% when tested in serial samples collected within
24 h of admission in 633 patients presenting with chest pain, of
which 122 had an AMI. The concordances of the AxSYM cTnI with the
Stratus cTnI, OPUS cTnI, and Access cTnI were 95.3%, 95.1%, and
94.3%, respectively, from patients with suspected AMI. The AxSYM cTnI
demonstrated excellent clinical specificity,
96%, in skeletal muscle
injury, chronic renal disease, and same-day noncardiac surgery
patients.
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